1. MSD P13038 Hearing Aid Design Detailed Design Review February 8, 2012

2. Team Members 2.1.13 Alissa Anderson Team Manager Conor Murphy System Integration Engineer Ronald Dries Lead Electrical Kelly Murosky Lead Mechanical Nanxi Yu EDGE Master Paula Garcia Secretary Eric Lew Budget Master Marbella Vidals Customer Relations Sarah Brownell Guide

3. Agenda 2.1.13 Project Overview (5 minutes) - Welcome Mechanical Design Review (30 minutes) - Enclosure review (function, assembly) - Assembly Review - Hot Topic: Assembly Feedback Electrical Design (40 minutes) - Electrical Feasibility - Circuit Schematic Review - Printed Circuit Board (PCB) Review - Hot Topic: Schematic Review Software Design (40 minutes) - Software Flowchart Review - Programming In Circuit - Processing Algorithm - Hot Topic: Programming in Circuit Project Plan (5 minutes) - Critical Path - Budget review

4. Mechanical

5. Functional Decomposition (ME) 1.11.13 amplify sound process sound capture sound modify sound filter sound adjust by frequency supply power store energy transform energy output energy accept energy interface with user accept ear fits comfortably protects user resists water and shock controls volume manages heat program device accepts data stores data user input recognizes input stores input adjusts system to input raise sound level track power level modify function to data output sound Key Needs: (2) Fits most adult ears ages 15-25 years (3) Device does not draw negative attention (4) Device supports an active lifestyle (7) Device is rechargeable by computer USB

6. Product Concept 1.2.13 Interface with standard ear tube and ear molds battery enclosure round enclosure transfer module

7. Round Enclosure (No Transfer Module) 2.1.13 outlet for wires to BTE enclosure 5 way button up = volume up down = volume down right = profile up left = profile down in = power on/off micro USB opening - to interface with transfer module pin to interface with transfer module for stability holes for microphone sound capture

8. CAD Proto 1- Rotation Feature 2.1.13 Top Closed Top Open Front Closed Front Open Outer blue “ring” rotates about the main enclosure allowing user to hide the micro-USB hole. Rotation is controlled by grey wire stem. Proto 2 Changes: (1) Update microphone hole locations (2) Improve ring assembly

9. How to attach Transfer Module 2.1.13 (1) rotate blue ring down (2) expose micro usb port (3) add transfer module. module will be secured by female micro USB (not shown) and stability pins stability pins (4) wear and enjoy!

10. Battery Enclosure 2.1.13 micro USB (power charging) Batteries slide out of enclosure when they need to be replaced wires to round enclosure Proto 2 Changes: (1) Battery Clips (2) PCB Standoffs

11. Proto-2 Change List 2.6.13 Planned Changes as of February 7, 2012 (1) add PCB standoffs to bottom round enclosure and battery case (2) add standoff location for 5-way switch (3) increase size of transfer module and improve transfer module / enclosure interface (4) update tube interface and solidify ear mold attachment plan (5) Add battery clips A B C D E F G H

12. User Renderings 1.2.13

13. Material Selection 2.6.13 Sabic’s Cycolac acrylonitrile-butadiene-styrene (ABS) thermoplastic resin Grade MG94 Superior flow, injection molding ABS Good impact resistance Best for thin-wall applications Medical biocompatibility Gamma and ethylene oxide (EtO) sterilization properties FDA and ISO 10993 compliant Chemical resistance Flame-retardancy that meets regulatory and safety standards Handles temperatures up to 110 C Broad range of colors

14. Material Properties 2.6.13

15. Test Plans (ME) 1 of 2 2.1.13 Spec # SourceSpecification Direc tion Units of measure MarginalIdealTest Plan S8 CN11, CN12 Maximum temperature at outside surface of device minoF body temp + 10 body temp Temperature sensor on final product to measure operating temperatures S10 CN4, CN6, CN10, CN11 Weight of earpieceming<15<12 weigh final product using scale S18CN9 Attaches to a standard ear tube and ear mold yes/n o yes Test product with standard ear tub and ear molds S19CN14Manufactured cost (estimated)min$<2000<1000Mathematical Analysis

16. Test Plans (ME) 2 of 2 2.1.13 Spec # SourceSpecification Direc tion Units of measure MarginalIdealTest Plan S9 CN2, CN4, CN11 Range of adult ear size accommodated maxpercentile25th to 75th 5th to 95th Heuristic Analysis Dimensional Analysis to prove the final product S14CN3 Percent of surveyed people who identify a picture of the device as something other than a hearing aid. maxpercent>60>80Heuristic Analysis S15CN3 Percent of surveyed hard of hearing people who prefer the form of the new device to standard behind the ear hearing aids maxpercent>50>75Heuristic Analysis S16CN3 Percent of surveyed hearing people who would use the device for Bluetooth or music listening maxpercent>50>70Heuristic Analysis S17CN11 Percent of surveyed people who feel the device is comfortable to wear maxpercent>60>80Heuristic Analysis

17. Key Risks (ME) 2.1.13 IDRisk ItemEffectCause Likeli hood Severit y Impo rtanc e Action to Minimize RiskOwner 8 Parts break during system integration Prototype (or final product) cannot be assembled; schedule pushed back Failure to work carefully with parts; poor material choice; failure of EE and ME teams to communicate with part sizes 236 Work carefully with finished parts; During alpha and beta prototypes, work with a variety of materials and companies to find best quality; order multiple prototypes and electrical components to replace broken parts Conor 9 Parts do not assemble Prototype (or final product) cannot be assembled; schedule pushed back Failure to review CAD and complete full tolerance analysis; failure of EE and ME teams to communicate with part sizes 236 Complete full tolerance analysis and CAD review prior to ordering final 3D print Kelly 22 Unable to create Button Interface that meets space constraints and is water resistant Cannot interface part electrically; miss waterproof customer need Poor switch device choice 236 Prototype with button; research more options for waterproofing connection Ali Anderson, Nanxi Yu 26 Rapid Prototyping tolerances Design will not be with in specifications; parts will not assembly 3D printing company cannot support required tolerances 236 Seek advice from experts. Research companies and obtain quotes. Kelly Murosky

18. EE

19. Functional Decomposition (EE) 1.11.13 amplify sound process sound capture sound modify sound filter sound adjust by frequency supply power store energy transform energy output energy accept energy interface with user accept ear fits comfortably protects user resists water and shock controls volume manages heat program device accepts data stores data user input recognizes input stores input adjusts system to input raise sound level track power level modify function to data output sound Key Needs: (1) Device amplifies sound (7) Device charges via USB port

20. Round PCB (EE/CE) 2.1.13

21. Battery Layout (EE/CE) 2.1.13

22. MSD 1 Unit Test Plans (EE/CE) 2.1.13 Test EE/C E Test DescriptionExpected OutcomeEquipment Needed Microphone Unit Test EE This test will test the functionality of the microphone. We will setup a microphone and connect its ouputs to an oscilloscope. Then observe the output as we talked into it We will see what the output of the microphone is and be able to determine if the level of output from the micophone is too high for the ADC on the DSC. Also we will get a better understanding of how the microphone works. Also determine how the outputs of the two mics is different Oscilloscope Microphone Speaker Unit Test EE This will test the functionality of the speaker. A speaker will be setup and we will connect its input to a signal generator. We will then be able to observe how the speaker works The expected outcome of this test is to determine that the speaker functions, and what kind of amplitude is required to make the speaker function. Waveform Generator Oscilloscope Speaker Bandpass filter and Pre- Amplification Test EE This will test the functionality of the bandpass RC filter and the pre- amplification instrumentation amplifier. We will test the system by applying signals of varying frequency and amplitude, and measuring the output signals produced. The expected output of the test should be a reduction in amplitude of frequencies outside of our desired range of 200Hz-800Hz, with the amplitude of the output signal before amplification being less than one-half of the input signal. We should also see desired frequencies amplified to a level in which they can be evaluated by the ADCs of the DSC. Breadboard, Oscilloscope, Waveform Generator, Instrumentation Amplifier, Resistors and capacitors of desired values Battery Charger Unit Test EE The battery charger will be wired up on a breadboard like it will be in the final circuit. We will then apply the correct input voltage to the battery charger circuit and attempt to charge the batteries that we purchased. This will show us that the battery charger functions properly. This test will be performed by measuring the batteries during charging to see if they are actually charging, then discharging the batteries in a way similar to the device's operation. We can also experiment with the battery charging circuit to make it as optimized as possible. Battery Charger IC Batteries Breadboard Multimeter

23. MSD 1 Unit Test Plans (EE/CE) 2.1.13 Test EE/C E Test DescriptionExpected OutcomeEquipment Needed Battery Charger/ Battery connected to DSC EE/CE Connect the battery charger circuit/batteries to a breakout board for the DSC This test will make sure that the DSC can be powered by the batteries, and show that there aren't any problems with the battery charging battery system when connected with the DSC Batteries Battery Charger Circuit Freescale DSC Eval Board Multimeter Test the 5-Way Tactile Switch EE/CE This test will prove the functionality of the switch. The switch will be wired up on a breadboard. Then it will be probed as the different directions are pressed to determine the output of the switch. We will have a clear understanding of how exactly the switch works after this test. As well as we will know if the switch is active high or active low which will be needed for when we use the switch to detect button presses 5-Way Tactile Switch Multimeter Integration Testing Evaluation boards EE/CE Connect the microphone, speaker, and switch to the DSC connect the microphone input, and the output of the DSC to an oscilloscope. This will take the functioning units that we previously tested and begin to test them as a whole. The point of this is to use the microphone to input actual speech to the DSC and observe how the processing algorithm works for actual speech. Changes/tweaks will be made to optimize the output. Oscilloscope Microphone Speaker Freescale DSC Eval Board 5-way Tactile Switch PCB Testing 1EE/CE First protoype PCB's will be connected together and tested to show correct operation of components, Also test programming of DSC The batteries power the circuit as required, the usb charging functions, the DSC can be programmed and runs the same as when using the eval board. Initial PCB's Oscilloscope Multimeter

24. Round Circuit Schematic 2.1.13

25. Round PCB Schematic 2.1.13

26. Battery Circuit Schematic 2.1.13

27. Back PCB with Planes Shown 2.1.13

28. Back PCB without Planes Shown 2.1.13

29. Top Layer of Back Piece PCB 2.1.13

30. Bottom Layer of Back Piece PCB 2.1.13

31. Key Risks (EE) 2.1.13 IDRisk ItemEffectCause Likeli hood Severit y Impo rtanc e Action to Minimize Risk Own er 27 PCB Company cannot cut custom edges Team will be forced to re-design PCBs to accommodate straight edges; changing the board shape may hinder EE ability to properly route traces Failure to research PCB process prior to creation 339 Call PCB company and confirm manufacturing abilities. Change companies or adjust board prior to ordering Eric 28 PCB software is only supported by a single company (PCB Express) Team is forced to order board from PCB Express; cannot look for alternative price, manufacturing options, etc. Failure to research PCB process prior to creation 313 Cannot avoid risk based on team decision to use PCB Express. Eric 29 PCB Express does not assemble boards Team will be forced to hand-solder surface mount components Choosing a company that does not support PCB assembly 326 Call PCB Express and verify if they support assembly; if they do not, team must investigate surface mount support on campus Eric 30 Freescale chip requires additional hardware to reprogram Product loses ability to be reprogramed (deliverable) Miss-reading the Freescale chip documentation 339 Contact Freescale immediately and research reprograming options. Ron

32. CE

33. Functional Decomposition 1.11.13 amplify sound process sound capture sound modify sound filter sound adjust by frequency supply power store energy transform energy output energy accept energy interface with user accept ear fits comfortably protects user resists water and shock controls volume manages heat program device accepts data stores data user input recognizes input stores input adjusts system to input raise sound level track power level modify function to data output sound Key Needs: (1) Device amplifies sound (7) Device charges via USB port

34. Mode Change / Standby Flow Chart (CE) 2.6.13

35. Volume Flow Chart (CE) 2.6.13

36. Sound Modification Flowchart (CE) 2.6.13

37. Programming in Circuit (CE) 2.6.13 Programming Options JTAG/ONCE connector SCI (Serial Communication Interface) i2C Major issue is how to program the DSC in the circuit (on the PCB) Possible Solutions Detachable JTAG connector USB to SCI RS232 to SCI JTAG/ONCE also allows for debugging of DSC as well as programming USB or RS232 to SCI requires additional hardware that will need to be built in a separate box. JTAG/ONCE connects to USB port of computer then to the hearing aid.

38. Processing Algorithm (CE) 2.6.13 Basic idea behind amplifying sound for this project is to : - Collect samples of human speech - Take the Fourier transform of the samples once a predetermined number has been reached - Walk through samples in the frequency domain and multiply by the gain - Take the inverse Fourier transform of the modified data to bring it back to the time domain - Output result through the DAC to the speaker Sample code from Freescale to perfom an FFT on values in an ADC buffer res = dfr16RFFT(pRFFT, (FRAC16 *) &AdcBuffer[AdcReadIndex], (dfr16_sInplaceCRFFT *) &FFTInplaceBuf[0]); The sample code takes in a signal performs the FFT and outputs the highest frequency to the terminal.

39. MSD 1 Unit Test Plans (EE/CE) 2.1.13 Test EE/C E Test DescriptionExpected OutcomeEquipment Needed Test ADC/ ADC interrupt CE Put a simple signal/sinusoid into the Freescale DSC eval board to determine that the ADC is configured correctly and that an interrupt can be generated and handled. Measure the signal before putting it into the ADC to ensure it does not burn anything The signal will generate an interrupt on the ADC pin and call and interrupt service handler. This will ensure that we can detect ecternal events coming into the system on the ADC port SignalGenerator Freescale DSC Eval Board Oscilloscope/Multimeter Test GPIO/GPIO interrupts CE The switch will be wired up to the GPIO ports defined for the different functions that we would like to implement. We will then move the switch to determine that each of the interrupts is generated as we had design them to work. If we can detect and handle all of the interrupts from the switch then we know that this functionality is working and the ports and pins that we had chosen for each of the functions is working correctly 5-Way Tactile Switch Freescale DSC Eval Board Test Volume Adjust CE Put a simple signal into the the ADC of the Eval kit, the interrupts have already been tested at this point so this will be testing the interrupt service routine, or the interrupt handler. The volume button will be pressed up and down to simulate the user changing the volume level The output signal should vary from the input signal according to if the volume is increased or decreased. The input and output of the system will be shown pn an oscilloscope and the output should avry with the volume level selected. Signal Generator Oscilloscope 5-Way Tactile Switch Freescale DSC Eval Board

40. MSD 1 Unit Test Plans (EE/CE) 2.1.13 Test EE/C E Test DescriptionExpected OutcomeEquipment Needed Test Mode Select CE Put a simple signal into the the ADC of the Eval kit, the interrupts have already been tested at this point so this will be testing the interrupt service routine, or the interrupt handler. The mode button will be pressed right and left to simulate the user changing the mode The outpust signal should vary depending on what mode the user is currently in/switched too. The modes will vary the non volume adjusted gains of the hearing aid, so the signal should vary much like the volume is being adjusted, just with the volume level set to 0. Signal Generator Oscilloscope 5-Way Tactile Switch Freescale DSC Eval Board Test StandbyCE Press the tactile switch in to put the hearing aid into a standby/power down mode. The hearing aid should go into a powered down state and no processing should be done at this point. TO return back into a processing state the switch must be pressed again. 5-Way Tactile Switch Freescale DSC Eval Board Initial Sound Processing Test CE Put a simple signal into the ADC of the eval kit, measure the input signal and output signal on an oscilloscope to visualize how the sound is being manipulated by the DSC The output signal should be amplified by a value determined by the gain we would like to have for the system. This will give an indication of how exactly the processing is working on a simple test signal. We can then experiment with the sound processing to tweak it or add to it. With the simple signal it should be easier to implement and see the result of the processing. Oscilloscope Signal Generator Freescale DSC Eval Board

41. MSD 2 Product Test Plans (EE/CE) 2.1.13 Spec # SourceSpecificationDirection Units of measure MarginalIdealTest Plan S1CN1 Lowest level of sound detected mindB<60<30 Place microphone and speaker into Audiologist Test equipment run low sound scenario and see hearing aid response S2CN1Frequencies amplifiedmaxHz300-700085-8000 Place microphone and speaker into Audiologist Test equipment and look at response of the hearing aid to the input S3 CN1, CN6 Maximum amplificationtargetdB85-9590 Place Mic and Speaker into test equipment, set gain to max and observe output response graph S4CN5 Levels of volume adjustment maxlevels520  Put simple sinusoid into hearing, probe input and output. See how output changes with different volume levels S5CN7Time to charge earpieceminminutes<60<30 Record the time to charge product S7CN7 Connects to standard USB 2.0 computer port targetyes/no yes Plug hearing aid into USB 2.0 port. Measure voltage/current from battery charger to determine if batteries are charging S12CN8 Earpiece battery life at maximum amplification maxhours>16>48 Run product at max power and record the battery life

42. Proposed Budget 1.11.13 ItemQtyCost ea.Total Evaluation Boards7$200$1400 Microphones5$0 Microprocessor3$5$15 Amplifier components1$70 Speaker5$0 USB Interface1$20 Rechargeable Battery10$15$150 PCB4$100$400 Acoustic Test Stand1$500 3D Printing Costs7$75$525 Customer Survey Incentive 1$50 MiscellaneousXX$1000 TOTAL$4130

43. Timeline: Critical Dates 2.1.13 DateEventDRI Jan 29order proto 1 enclosureAli February 15Printed Circuit Board (PCB) 1.0 Ordered Conor February 18order proto 2 enclosureAli March 10order final PCBConor March 18Order final enclosures for integrationAli April 1Start integration and debugALL April 26WORKING PROTOTYPE DUEALL May 4Imagine RITALL May 10Final MSD Review (Week 10)ALL

44. Updated Team Risks 2.1.13 IDRisk ItemEffectCauseLSIAction to Minimize RiskOwner 13 Loss of team member (ex: last minute coop) Team loses knowledge and creates more work for other team members. Cause may be due to graduation requirements / personal class choices / personal emergency 236 Cross train between positions. Team manager should be aware of everyones' projects and responsibilities (in the event that one team member leaves, the team manager can help divide the extra work and reassign responsibilities) by checking edge for on a weekly basis to ensure each member updates their documentation. Prior to exit, exiting member should review with the team and transfer all knowledge (if possible). Alissa Anderson 14 Project exceeds budget allowance ($5000) Team can no longer financially continue with project Team member other then "budget master" made unapproved purchase; parts are more expensive than anticipated; emergency purchases are more expensive due to overnight shipping 133 Track expenses and purchase items; Budget Master makes and records all purchases Eric Lew 15 Team member overloaded with work outside of MSD Team loses support from stressed team member (external to MSD)236 team members should be constantly aware and proactive about academic schedules to foresee high stress work weeks. team members should vocalize stress / busy weeks to team and team manager so that their responsbile MSD responsibilities can be reassigned or other team members can assist Alissa Anderson, Kelly Murosky, Ronald Dries, Conor Murphy, Paula Gracia,Nanxi Yu, Eric Lew, Marbella Vidals

45. Backup

46. MatLab 1.11.13 Code Overview: amplifies sound and reduces noise for a patient with “ski-slope” hearing loss Frequency Shaper: Breaks hearing loss into piecewise functions and calculates the required gain for each section Applies Fourier Transform on the input signal, and multiplies transformed signal by the required gain function The Inverse Fourier Transform of the signal converts signal back to the time domain. Amplitude Shaper: Output signal is inputted into an amplitude shaper to remove noise and confirms signal is in acceptable (not harmful) range.

47. Types of Ear Molds 1.9.13 Oticon Intiga Hearing aid with “dome” style earmold Oticon DigiFocus II Hearing aid with “custom” style earmold Motorola HK200 Bluetooth Headset, “dome” style earmold

48. Customer Needs 1.11.13 Customer NeedRankDescription CN19The device amplifies sound CN29The device fits most adult ears ages 15-25years CN39The device does not draw attention to the user as a hard of hearing individual CN49The device supports an active lifestyle (stays on the ear during everyday activities and light activities) CN59The device includes a way for the user to adjust the volume while on the ear CN69The device is safe to use CN79The device is rechargeable by computer USB port CN83The power in the earpiece should lasts at least 48 non-continuous hours CN93The device interfaces with a standard tube and ear mold CN103The weight of the device is similar to existing earpieces CN113The device is comfortable to wear CN123The device does not generate excessive heat during use or charging CN131 The device includes an additional method for toggling between functions (for later use to switch between programs or turn on Bluetooth, etc.) CN141The device has a cost similar to current devices when in production CN150Optional: The device communicates with a cell phone or music player by Bluetooth CN160Optional: The device has noise cancellation capabilities

49. Specifications 1.11.13 Spec #SourceSpecificationDirectionUnits of measureMarginalIdealNotesDRI S1CN1Lowest level of sound detectedmindB<60<30lowest range of normal hearingEE S2CN1Frequencies amplifiedmaxHz300-700085-8000 marginal values are those used in radio, 85 is lowest male voice EE S3CN1, CN6Maximum amplificationtargetdB85-9590max considered safeEE S4CN5Levels of volume adjustmentmaxlevels520adjusted in steps or continuousEE S5CN7Time to charge earpieceminminutes<60<30 EE S7CN7Connects to standard USB 2.0 computer porttargetyes/no yes EE S8CN11, CN12Maximum temperature at outside surface of deviceminoFbody temp + 10body temp MEE E S9CN2, CN4, CN11Range of adult ear size accommodatedmaxpercentile25th to 75th10th to 90th ISE S10 CN4, CN6, CN10, CN11 Weight of earpieceming<15<12 marginal values will depend on ergonomic info ISE S12CN8Earpiece battery life at maximum amplificationmaxhours>16>48 EE S14CN3 Percent of serveyed people who identify a picture of the device as something other than a hearing aid. maxpercent>60>80 team should conduct surveys (at imagine RIT? thoughts?) ID S15CN3 Percent of surveyed hard of hearing people who prefer the form of the new device to standard behind the ear hearing aids maxpercent>50>75team should conduct surveysID S16CN3 Percent of surveyed hearing people who would use the device for Bluetooth or music listening maxpercent>50>70team should conduct surveysID S17CN11 Percent of surveyed people who feel the device is comfortable to wear maxpercent>60>80team should conduct surveysID S18CN9Attaches to a standard ear tube and ear moldyes/no yes maybe should interview audiologist for final decision ID S19CN14Manufactured cost (estimated)min$<2000<1000 not as important in first round of prototyping, but should be considered ISE

50. Proto 2 Change List 2.1.13